Federal Register, Volume 75 Issue 38 (Friday, February 26, 2010)

[Federal Register Volume 75, Number 38 (Friday, February 26, 2010)]
[Notices]
[Pages 8970-8971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3978]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0391]

Guidance for Industry on Submission of Documentation in
Applications for Parametric Release of Human and Veterinary Drug
Products Terminally Sterilized by Moist Heat Processes; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Submission of
Documentation in Applications for Parametric Release of Human and
Veterinary Drug Products Terminally Sterilized by Moist Heat
Processes.'' This guidance provides recommendations to applicants on
information to include in support of parametric release for sterile
products terminally sterilized by moist heat when submitting a new drug
application (NDA), abbreviated new drug application (ANDA), new animal
drug application (NADA), abbreviated new animal drug application
(ANADA), or biologics license application (BLA).

DATES: Submit written or electronic comments on agency guidances at any
time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002; the Communications Staff
(HFV-12), Center for Veterinary Medicine, 7519 Standish Pl., Rockville,
MD 20855; the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), 1401
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed
adhesive label to assist that office in processing your requests. The
guidance may also be obtained by mail by calling CBER at 1-800-835-4709
or 301-827-1800. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
Marla Stevens-Riley, Center for Drug Evaluation and Research (HFD-
600), Food and Drug Administration, 7500 Standish Pl., Rockville, MD
20855, 240-276-9310, or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852, 301-827-6210; or
Mai Huynh, Center for Veterinary Medicine (HFV-142), Food and Drug
Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8273.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry
entitled ``Submission of Documentation in Applications for Parametric
Release of Human and Veterinary Drug Products Terminally Sterilized by
Moist Heat Processes.'' The guidance addresses the information that
should be submitted in an NDA, ANDA, NADA, ANADA, or BLA in support of
parametric release for sterile products terminally sterilized by moist
heat.
``Parametric release'' is defined as a sterility assurance release
program where demonstrated control of the sterilization process enables
a firm to use defined critical process controls, in lieu of the
sterility test, to fulfill the intent of 21 CFR 211.167(a). Under this
strategy, market release of terminally sterilized products can be based
upon meeting the defined sterilization parameters and not on performing
an approved sterility test. Meeting the requirements of the parametric
release process can provide greater assurance that a batch meets the
sterility requirement than can be achieved with a sterility test of
finished units drawn from the batch.
Parametric release allows manufacturers to replace sterility
testing of samples drawn from the finished product as a release
criterion with acceptance criteria for the control of identified
process parameters. Parametric release of the batch is then based on
documented evidence of the control of critical parameters, removing the
need for testing of samples drawn from the finished product.
An application to FDA is required to obtain approval for parametric
release. The approval of parametric release is based on an assessment
of the applicant's proposed critical process parameters and how they
are controlled. Demonstrated reliability of the production terminal
sterilization cycle, microbiological control and monitoring, and
control of production cycle parameters within established validated
limits is part of this assessment. FDA conducts scientific evaluation
of the parametric release program as part of a cooperative effort
between FDA product reviewers and the compliance program.

[[Page 8971]]

On August 5, 2008 (73 FR 45454), FDA announced the availability of
the draft version of this guidance. The public comment period closed on
October 6, 2008. A number of comments were received, which the agency
considered carefully as it finalized the guidance and made appropriate
changes. Most of the changes to the guidance were made to clarify
statements in the draft guidance.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
agency's current thinking on inclusion of recommended information to
support applications for parametric release of human and veterinary
drug products terminally sterilized by moist heat processes. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information requested in the guidance is covered under
FDA regulations at 21 CFR 314.50, 314.70, and 314.81(b)(2) for human
drugs; 21 CFR 514.1, 514.8, 514.8(b)(4) and (c) for animal drugs; and
21 CFR 601.2 and 601.12 for biologics. The collection of information is
approved under the following OMB control numbers: 0910-0001 for human
drugs, 0910-0600 for animal drugs, and 0910-0338 for biologics.

III. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

Dated: February 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3978 Filed 2-25-10; 8:45 am]
BILLING CODE 4160-01-S